Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia

NCT02130765 | Terminated Results DMC FDA Device

• 1 other identifier: SJM-CIP-0005
• Study Type: interventional
• Target: 64
• Locations: 5 countries
• Sites: 38

Brief Summary

To demonstrate that scar-based ventricular tachycardia (VT) ablation using the FlexAbility™ ablation catheter system results in a superior clinical outcome compared to routine drug therapy in subjects with documented Monomorphic Ventricular Tachycardia \[MMVT\] (both ischemic and non-ischemic) while maintaining an acceptable safety profile.

Conditions

Monomorphic Ventricular Tachycardia

Keywords

Monomorphic Ventricular Tachycardia; Ischemic; Non-ischemic; Catheter Ablation

Outcome Measures

Primary Outcomes (2)

• Number of Subjects Who Experienced an ICD Shock Event.

  Primary Effectiveness endpoint: Number reported is number of subjects who experienced an ICD shock event (including both appropriate and inappropriate) through 12 month follow up

  12 months

• Number of Subjects Who Experienced a Select Serious Adverse Event

  Primary Safety Endpoint: Number of subjects who experience a select serious adverse events within the 30 day follow up. Those events are anticipated, associated with catheter ablation, and are cardiovascular, pulmonary, or peripheral vascular in nature, as listed in the Primary Safety Events List.

  30 days

Secondary Outcomes (1)

• Number of Subjects That Had a Cardiovascular (CV) Hospitalizations or CV-related ER Visit

  12 months

Study Arms (2)

Drug with ICD/CRT-D

NO INTERVENTION

Implantable cardioverter defibrillator (ICD) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D) with routine drug therapy

Cardiac catheter ablation with ICD/CRT-D

ACTIVE COMPARATOR

Cardiac catheter ablation with ICD/CRT-D with routine drug therapy

Device: Cardiac catheter ablation with ICD/CRT-D

Interventions

Cardiac catheter ablation with ICD/CRT-D DEVICE

Cardiac ablation catheter system

Cardiac catheter ablation with ICD/CRT-D

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is receiving a new St.Jude Medical (SJM) Implantable Cardioverter Defibrillator (ICD) or SJM Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implant, which has study required programing capabilities and is appropriate for remote monitoring. Subjects who have received the ICD / CRT-D up to 90 days prior to enrollment are also eligible.
• Patient who has a high risk of ICD shock as shown by at least one documented Monomorphic VT (MMVT)\*\* by one or more of the following:
• Spontaneous MMVT or Inducible MMVT during electrophysiology (EP) Study or Inducible MMVT during Non-Invasive Programmed Stimulation (NIPS) Study
• to 75 years of age
• Patient has been informed of the nature of the study and has agreed to its provisions and provided written informed consent approved by the Institutional Review Board.
• Note Pleiomorphic ventricular tachycardia (VT) (multiple MMVT morphologies) is acceptable but polymorphic VT or ventricular fibrillation (VF) is not.

You may not qualify if:

• Any history of stroke
• S-T elevation myocardial infarction (MI) or previous cardiac surgery within 60 days prior to enrollment
• Patient is pregnant or nursing
• Patient has New York Heart Association (NYHA) class IV heart failure
• Patient has incessant ventricular tachycardia (VT) necessitating immediate treatment (Patients with Incessant VT have continuous sustained VTs that recur promptly despite repeated intervention for termination over several (≥3) hours)
• Patient has VT/VF thought to be from channelopathies
• Limited life expectancy (less than one year) according to Investigator
• Patient has current class IV angina
• Recent coronary artery bypass graft (CABG \< 60 days) or percutaneous coronary intervention (PCI \< 30 days)
• Patient is currently participating in another investigational drug or device study
• Patient is unable or unwilling to cooperate with the study procedures
• Known presence of intracardiac thrombi (i.e., positive Transesophageal Echocardiogram (TEE) for LA or LV clot). TEE is required for history of left atrium (LA) or left ventricle (LV) clot and recommended for history of atrial fibrillation (AF) with CHADS \> 1
• Prosthetic mitral or aortic valve
• Mitral or aortic valvular heart disease requiring immediate surgical intervention
• Major contraindication to anticoagulation therapy or coagulation disorder

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (38)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

USC University Hospital

Los Angeles, California, 90033, United States

Location

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

University of California at San Diego (UCSD) Medical Center

San Diego, California, 92103, United States

Location

University of California at San Francisco

San Francisco, California, 94143, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Mid-America Cardiology Associates

Kansas City, Kansas, 66160, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins University Hospital

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Washington University School of Medicine - Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Mercy Hospital St. Louis

St Louis, Missouri, 63141, United States

Location

New York University Hospital

New York, New York, 10016, United States

Location

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Mt. Sinai Hospital

New York, New York, 10029, United States

Location

Staten Island University Hospital - North

Staten Island, New York, 10305, United States

Location

Sanger Clinic

Charlotte, North Carolina, 28203, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19118, United States

Location

Vanderbilt Heart and Vascular Institute

Nashville, Tennessee, 37232, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Memorial Hermann Hospital

The Woodlands, Texas, 77380, United States

Location

Intermountain Heart Rhythm Specialist

Murray, Utah, 84107, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Royale Adelaide Hospital

Adelaide, 5000, Australia

Location

Hopital d'adulte de la Timone

Marseille, Alpes, 13005, France

Location

CHU Trousseau

Chambray-lès-Tours, Centre-Val de Loire, 37170, France

Location

Clinique Protestante

Lyon, 69300, France

Location

Hôpital du Haut Lévêque

Pessac, 33604, France

Location

Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

Location

Freeman Hospital

Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Ischemia

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Limitations and Caveats

Low enrollment rates resulted in early termination. Therefore the study did not reach the target number of participants needed to achieve target power and statistically reliable results, and statistical hypothesis testing was not performed.

Results Point of Contact

• Title: Senior Clinical Research Scientist
• Organization: Abbott

amber.miller@abbott.com

6517562885

Study Officials

• Andrea Natale, MD

  Texas Cardiac Arrhythmia Research Foundation

  PRINCIPAL INVESTIGATOR

• Francis Marchlinski, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: May 5, 2014
• Study Start: November 1, 2014
• Primary Completion: July 25, 2016
• Study Completion: July 25, 2016
• Last Updated: February 12, 2019
• Results First Posted: October 15, 2018

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); FR (4); US (30); IT (1); GB (2)